Chemoprevention of Colorectal Adenomas

This is a multicenter, randomized, parallel group, prospective, double blind, placebo
controlled clinical trial of chemoprevention in patients at increased risk of developing
colorectal cancer (CRC). The Colotech combination treatment (acetylsalicylic acid, 1α
25-dihydroxy cholecalciferol, and calcium carbonate) will be compared to placebo with regards
to safety and efficacy during 3 years of treatment. The randomized treatment period will be
preceded by a 3-week single blind placebo run-in period, which will assess patient's
compliance to treatment. In order to collect data on the durability of treatment effect,
follow-up data from a surveillance colonoscopy will be collected two years after the 3-year
colonoscopy.

Inclusion Criteria:

- Patients 40-75 years of age, both sexes.

- Colonoscopy including the cecum at trial entry

- The removed adenoma(s) have be to tubular, tubulovillous or villous, and fulfill one
of the three following criteria:

1. one adenoma with diameter ≥ 1 cm

2. ≥ 2 adenomas of any size

3. an adenoma of any size and familial disposition for colorectal cancer, as long as
the person is a first degree relative with a colorectal cancer patient

Exclusion Criteria:

- Familial Adenomatous Polyposis Syndrome

- Member of a family with hereditary non-polyposis colorectal cancer (HNPCC)

- Proctocolectomy (colonic and/or rectum resection permitted).

- Inflammatory bowel disease (Crohn´s disease, Ulcerative Colitis).

- Ischemic cardiovascular disease.

- Patients with known gastro-duodenal ulcer at time of inclusion.

- Cancer within the past 5 years